Overview

This trial is active, not recruiting.

Condition cervical cancer
Treatment questionnaire
Sponsor M.D. Anderson Cancer Center
Collaborator National Cancer Institute (NCI)
Start date September 2002
End date December 2016
Trial size 165 participants
Trial identifier NCT00522223, 1R03CA097869-1, ID02-376

Summary

Primary Objectives:

1. To assess the entire range of sexual functioning (desire, arousal, orgasmic capacity, dyspareunia, and sexual satisfaction) over the course of treatment and early follow-up in patients with local and locally advanced cervical cancer;

2. To assess general cancer-related QOL over the course of treatment and early follow-up in patients with local and locally advanced cervical cancer;

3. To characterize the relationship between sexual dysfunction and overall cancer-related QOL over time; and

4. To identify factors that may predict better sexual function outcomes in patients treated for cervical cancer.

Secondary Objectives:

1. Describe vaginal changes objectively via measurement of vaginal length.

2. Demonstrate reliability of the vaginal length instrument and its applicability to future studies.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Questionnaire
questionnaire Survey
Participants who are treated with radiation therapy: Questionnaires 5 times. Participants who undergo a radical hysterectomy: Questionnaires 4 times.

Primary Outcomes

Measure
To evaluate sexual functioning and the quality of life (QOL) in women with cervix cancer.
time frame: 7 Years

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: 1. Eligibility criteria for 20 women in the pilot study (see Treatment Plan for details) of feasibility include: - History of cervical cancer (within 3 months to 5 years of diagnosis) - English or Spanish-speaking - Ability to give informed consent 2. Eligibility criteria for the main study: - New diagnosis of local or locally advanced cervical cancer - English or Spanish-speaking - Ability to give informed consent Exclusion Criteria: 1. Patients who are illiterate 2. Patients who have undergone an exenteration 3. Patients who do not speak English or Spanish

Additional Information

Official title Sexual Functioning and Quality of Life in Women With Cervical Cancer
Principal investigator Diane C. Bodurka, MD
Description FIRST PART: NO LONGER RECRUITING There are two parts to this study. The first part is called a "feasibility study" and will include 20 women who have been treated for cervix cancer in the past. These women will be asked to fill out questionnaires to evaluate their quality of life and sexual functioning. The questionnaires will only be completed once. The questionnaires will be filled out during routine clinic visits. SECOND PART: RECRUITING If the feasibility study is successful (if the majority of the 20 women are able to complete the questionnaires), the second part of the study will be performed with a larger number of women who have been diagnosed with cervix cancer but who have not yet begun treatment. Patients who participate in this part of the study will also be asked to fill out the questionnaires described above. Participants who are treated with radiation therapy will be asked to complete questionnaires 5 times: before radiation treatment starts, at the time of the first ALTO, and 1 month, 4 months and 7 months after treatment ends. Vaginal measurements will only be done 4 times: at the time of first ALTO, and 1 month, 4 months and 7 months after treatment ends. Participants who undergo a radical hysterectomy will be asked to complete questionnaires and have a vaginal measurement 4 times: before surgery and 1 month, 4 months and 7 months after treatment ends. Vaginal measurements will only be done 4 times: at the time of first ALTO, and 1 month, 4 months and 7 months after treatment ends. The questionnaires take about 20 minutes to complete. The vaginal measurement is done by a doctor and takes less than a minute to complete. This is an investigational study. About 165 patients will take part in this multicenter study. About 135 patients will be enrolled at M. D. Anderson.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.